Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer

Completed · Phase 2

Conditions studied: Pancreatic Cancer Stage IV

In brief

The purpose of this study is to see if the combination of nivolumab + cabiralizumab + gemcitabine can give prolonged disease control in patients with advanced pancreatic cancer compared to gemcitabine alone.

Key facts

Study ID

NCT03697564

Run by

Hitendra Patel

People needed

2

Starts

2019-10-31

Expected to finish

2023-07-13

Last updated by the study team

2025-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed pancreatic adenocarcinoma with metastasis
• Must be off their prior cytotoxic regimen a minimum of two weeks but no more than four weeks from initiating trial treatment.
• Measurable disease by RECIST 1.1.
• Demonstrate adequate organ function
• Normal Vitamin D level.
• Able to submit an archival tumor specimen (primary or metastatic site). Patients with cytology only that do not have adequate archived tumor specimen available, will require a baseline biopsy.

You may not qualify if…

• Is currently participating and receiving trial therapy or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 3 weeks of the first dose of trial treatment.
• Hypersensitivity to cabiralizumab, nivolumab, or gemcitabine or any of its excipients.
• Previous malignancies (except non-melanoma skin cancers, and in situ bladder, gastric, colorectal, endometrial, cervical/dysplasia, melanoma, or breast cancers) unless complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period.
• Evidence of central nervous system (CNS) metastasis
• Participants with active, known, or suspected autoimmune disease.
• Current or history of clinically significant muscle disorders (e.g., myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels.
• Uncontrolled or significant cardiovascular disease
• Prior organ allograft or allogeneic bone marrow transplantation.
• Any uncontrolled inflammatory GI disease including Crohn's Disease and ulcerative colitis.
• Evidence of coagulopathy or bleeding diathesis.
• Has received prior therapy with a CSF-1R pathway inhibitors, anti-PD-1, anti-PD-L1, anti PD-L2, anti-CTLA-4.

Where it is running

• UCSD Moores Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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